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| Name | Class |
|---|---|
| CSSi Life Sciences | INDUSTRY |
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The purpose of this study is to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test in home use.
The MGC Health COVID-19 & Flu A+B Home Multi Test is a lateral flow immunochromatographic antibody assay intended for the simultaneous qualitative detection and differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from anterior nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection within five (5) days of symptom onset. This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user collected anterior nares swab samples from individuals aged 2 to 13 years.
The objective of the study is to determine the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test in a simulated home use environment.
This is an open label study to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test using information from the Quick Reference Instructions (QRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals - ages 14 and older | Experimental | This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older. |
|
| Individuals - ages 2 to 13 | Experimental | This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples. If the subject is under the age of 14, an adult lay-user will collect the sample. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGC Health COVID-19 & Flu A+B Home Multi Test | Diagnostic Test | self-collected direct anterior nares swab samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability of Quick Reference Instructions (QRI) - Critical Steps | Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. The observer completed an observation form for each subject assessing whether the subject or adult lay user completed each critical task, and whether the task was performed correctly. | 1 hour |
| Usability of Test Kit | Assess the usability of the kit for home use based upon subject evaluation. adult lay users filled out a questionnaire regarding the ease of understanding the instructions provided by the QRI for obtaining the sample, performing the test, and reading and interpreting the results, and the ease of completing each task. The subject or adult lay user used the following 5-digit score to answer the questions:
| one hour |
| Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation | Assess the usability of the QRI based upon observer evaluation. | 1 hour |
| Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results | Assess the usability of the QRI. Subjects or adult lay users were presented with 10 sample images of test results: 1 negative test, 7 positive tests, and 2 invalid tests. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Cattano, RN, MSN | CSSi LifeSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L&A Morales Healthcare | Miami | Florida | 33142 | United States |
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Thirty-four (34) subjects were screened and enrolled into the study. There were no screen failures or early terminations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Individuals - Ages 14 and Older | This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older. MGC Health COVID-19 & Flu A+B Home Multi Test: self-collected direct anterior nares swab samples |
| FG001 | Individuals - Ages 2 to 13 | This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples. If the subject is under the age of 14, an adult lay-user will collect the sample. MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o): adult lay user collected anterior nares swab sample |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usability Data Set | A total of 34 subjects were enrolled in the study. There were 15 subjects ranging in age from 2 to 13. The collection and result interpretation for these subjects under 14 were done by an adult lay user. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability of Quick Reference Instructions (QRI) - Critical Steps | Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. The observer completed an observation form for each subject assessing whether the subject or adult lay user completed each critical task, and whether the task was performed correctly. | Posted | Number | participants | 1 hour |
|
|
24 hours
This study was deemed to have a less than significant risk by IRB assessment, and no sites reported any adverse events during or after the study enrollment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usability Data Set | A total of 34 subjects were enrolled in the study. There were 15 subjects ranging in age from 2 to 13. The collection and result interpretation for these subjects under 14 were done by an adult lay user. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomaz Lovse | Medical Group Care | 239 631 1907 | tomaz.lovse@mgc.us |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2023 | Mar 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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This is an open label study to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test using information from the Quick Reference Instructions (QRI).
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| MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o) | Diagnostic Test | adult lay user collected anterior nares swab sample |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Usability of Test Kit | Assess the usability of the kit for home use based upon subject evaluation. adult lay users filled out a questionnaire regarding the ease of understanding the instructions provided by the QRI for obtaining the sample, performing the test, and reading and interpreting the results, and the ease of completing each task. The subject or adult lay user used the following 5-digit score to answer the questions:
| Posted | Mean | Full Range | Mean score on a scale | one hour |
|
|
|
| Primary | Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation | Assess the usability of the QRI based upon observer evaluation. | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| Primary | Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results | Assess the usability of the QRI. Subjects or adult lay users were presented with 10 sample images of test results: 1 negative test, 7 positive tests, and 2 invalid tests. | Posted | Number | Participants with correct interpretation | 1 hour |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
|
| How easy was it to understand how to collect the sample from your nose or from another person? |
|
| How easy or difficult was it to understand the instructions to swirl the swab in the collection tube |
|
| How easy was it understand how to lift the swab out of the liquid and squeeze in the collection tube |
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| How easy or difficult was it to insert the nozzle lid onto the sample collection tube? |
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| How easy was it to understand to add the sample from the collection tube to the sample well |
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| How easy or difficult was it to add the 3 drops into the test cassette? |
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| How easy or difficult was it to read the test results? |
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| How easy was it to understand the instructions on how to interpret the results of the test? |
|
| Positive COVID-19 |
|
| Title | Measurements |
|---|---|
|
| Image 4 - invalid test (Flu A line, no C line) |
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| Image 5 - positive Flu B |
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| Image 6 - positive Flu A, and Flu B |
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| Image 7 - negative |
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| Image 8 - positive COVID-19 and Flu A |
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| Image 9 - positive COVID-19 and Flu B |
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| Image 10 - positive COVID-19 |
|